TIDMYGEN
RNS Number : 9332B
Yourgene Health PLC
17 February 2022
Yourgene Health plc
("Yourgene" or the "Group" or the "Company")
Successful CTDA desktop review
Approval for sale of Clarigene(R) SARS-CoV-2 Test in the UK
Manchester , UK - 17 February 2022: Yourgene (AIM: YGEN), a
leading international molecular diagnostic group, announces that it
has received confirmation from the UK Health Security Agency that
the Clarigene(R) SARS-CoV-2 test (CE-IVD) ("Clarigene(R)") has been
approved under the requirements set out in the Medical Devices
(Coronavirus Test Device Approvals) (Amendment) Regulations 2021
("CTDA regulations").
The product will be included on the register of products that
have been approved under 38A(5) of the Medical Devices Regulations
2002, in due course:
https://www.gov.uk/government/publications/covid-19-test-validation-approved-products
Yourgene's primary source of COVID-19 revenues, PCR testing and
sequencing services, were unaffected by the extended time taken to
receive this approval under these newly introduced UK regulations,
as they were not reliant on selling Clarigene(R) or Clarigene(R)
achieving approval under CTDA regulations.
Following approval under CTDA regulations, Yourgene can now
actively market the Clarigene(R) test to new UK customers to meet
the needs of continued seasonal PCR testing. Clarigene will be one
of a small number of UK manufacturers with COVID-19 testing
products currently approved for sale in the UK.
Having recently provided upgraded guidance for the current
financial year on 17 January 2022, Yourgene intends to provide a
further progress update on trading following the March year
end.
The Directors of the Company take responsibility for this
announcement.
Yourgene Health plc Tel: +44 (0)161 669 8122
Lyn Rees, Chief Executive Officer investors@yourgene-health.com
Barry Hextall, Chief Financial Officer
Joanne Cross, Director of Marketing
Cairn Financial Advisers LLP (NOMAD) Tel: +44 (0)20 7213 0880
Liam Murray / James Caithie / Ludovico
Lazzaretti
Singer Capital Markets (Joint Corporate Tel: +44 (0)20 7496 3000
Broker)
Aubrey Powell / Tom Salvesen / George
Tzimas
Stifel Nicolaus Europe Limited (Joint Tel: +44 (0)20 7710 7600
Corporate Broker)
Nicholas Moore / Matthew Blawat / Ben
Maddison
Walbrook PR Ltd (Media and Investor Tel: +44 (0)20 7933 8780 or yourgene@walbrookpr.com
Relations)
Paul McManus / Alice Woodings Mob: 07980 541 893 / 07407 804 654
About Yourgene Health
Yourgene Health is an international molecular diagnostics group
which develops integrated genomic technologies and services
enabling genomic medicine. The group works in partnership with
global leaders in DNA technology to advance diagnostic science.
Yourgene primarily develops, manufactures, and commercialises
simple and accurate molecular diagnostic solutions, for
reproductive health, precision medicine and now infectious
diseases. The Group's flagship products include non-invasive
prenatal tests (NIPT) for Down's Syndrome and other genetic
disorders, Cystic Fibrosis screening tests, invasive rapid
aneuploidy tests, and a recent extension into the oncology space
with DPYD genotyping.
The launch of Yourgene Genomic Services has enabled Yourgene to
offer a global laboratory service network equipped to be a full
life-cycle partner for clinical, research and pharmaceutical
organisations to support partners at the preclinical, clinical, and
post-market stages to develop, manufacture, obtain regulatory
approval and commercialise new products and services. In addition,
Yourgene Genomic Services offers an NIPT and high throughput COVID
testing service.
In August 2020, Yourgene acquired Coastal Genomics , Inc., a
sample preparation technology company based in Vancouver, Canada,
enabling the Company to extend its offering and IP portfolio in the
DNA sample preparation sector. The acquisition increased Yourgene's
geographical penetration into the US and Canada, supplementing
existing coverage in the UK, Europe, MEA and Asia.
Yourgene Health is headquartered in Manchester, UK with offices
in Taipei, Singapore, the US and Canada, and is listed on the
London Stock Exchange's AIM market under the ticker "YGEN". For
more information visit www.yourgene-health.com and follow us on
twitter @Yourgene_Health.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking
statements. These forward-looking statements are not historical
facts but rather are based on the Company's current expectations,
estimates, and projections about its industry; its beliefs; and
assumptions. Words such as 'anticipates,' 'expects,' 'intends,'
'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions
are intended to identify forward-looking statements. These
statements are not guarantees of future performance and are subject
to known and unknown risks, uncertainties, and other factors, some
of which are beyond the Company's control, are difficult to
predict, and could cause actual results to differ materially from
those expressed or forecasted in the forward-looking statements.
The Company cautions security holders and prospective security
holders not to place undue reliance on these forward-looking
statements, which reflect the view of the Company only as of the
date of this announcement. The forward-looking statements made in
this announcement relate only to events as of the date on which the
statements are made. The Company will not undertake any obligation
to release publicly any revisions or updates to these
forward-looking statements to reflect events, circumstances, or
unanticipated events occurring after the date of this announcement
except as required by law or by any appropriate regulatory
authority.
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